DE19829620A1 - Guide wire for catheter - Google Patents

Abstract

The guide wire (1) has an inner core (2) of a number of wire strands without a core, or a single strand, where the inner core has an outer irregular surface covered with a high-molecular-weight polymer cladding (3). The outer surface (8) of the cladding is also uneven, following the structure of the wire core. The cladding consists of a resin with a fluor base, polyethylene, polyester, polypropylene, polyamide, polyurethane, polystyrene and their elastomers, polyvinyl chloride and silicon rubber. The material (7) on the surface, to show up on X-rays, consists of gold, silver, platinum, tungsten, bismuth oxide, palladium and tantalum.

Description

The present invention relates to a guide wire for guiding a medical device a hollow structure, such as a catheter or the like, which is in a human body directly or through an endoscope during a medical treatment or examination introduced becomes.

There have been medical treatments in recent years started to explicitly introduce techniques Ren or use which less by cuts cause damage to a human body stuff. In particular, instead of an operation with one cut, like an abdominal incision, Breast wall cut or the like, which for a Pa represents a heavy physical strain, examinations and treatments have recently started by inserting various catheters into a human che body cavity used. In the event that such Technique is generally used guidewire inserted through a catheter, which are introduced into a human body and a device such as the Kathe ter or the like, is along the guide wire led to a target cavity area. Many feet Wires of this type are used in an investigation or a treatment of a digestive organ, such as Example of a stomach, a duodenum, a gal lenganges, a gallbladder, a liver, a duct pancreaticus, a pancreas or the like det.  

Conventional guidewires for digestive organs ne, with such a technique one by incision caused small damage or such a mini malinvasive technique are used at for example in the Japanese patent application KOKAI No. 2-180277 and U.S. Patent 5,111,829 suggested. Each of these guide wires has an inner core made of a super elastic metal and an X-ray provided at the top steering contrast portion, and the entirety of the inner Kernes and the X-ray contrast portion is covered with a synthetic resin. The coating be sits a substantially uniform outer Diameter and an outer peripheral surface, which as a smooth and flat cylindrical surface without Roughness is designed.

However, in the case of the above described the outer peripheral surface made of synthetic The resin that covers the inner core is smooth cylindrical shape without roughness. Consequently, in the Case that a catheter by means of the above Guide wire is actually guided, the inner one Peripheral surface of the catheter in close contact with the smooth and flat outer peripheral surface of the Guide wire brought and adheres intensely to it. The frictional resistance when the guidewire slides, is large and worsens functionality when inserting and / or withdrawing a catheter.

In this regard, the Japanese use sample application KOKOKU No. 2-40992, the Japanese Pa tent registration KOKAI No. 62-231675, the Japanese Ge usage pattern KOKOKU No. 61-7735 and the American Patent US-A-4 579 127 guide wires proposed by each of which is trained in an uneven shape  has outer peripheral surface to the friction resistance stood to decrease a catheter or the like.

In the Japanese utility model application KOKOKU No. 2-40992 proposed guide wire is a tube-like part - the one with the inner core is freely in contact - from a net-like part forms or the outer peripheral surface of the tubular arena part is sprayed with a varnish celt effect processed or provided so that the outer peripheral surface of the tubular member is designed to be an uneven surface sits.

The guide wire according to the Japanese Pa tent registration KOKAI No. 62-231675 is a thin wire like inner core with a relatively thick coating layer coated, and the outer peripheral surfaces part of the coating layer is formed so that it un is.

In the guide wire according to the Japanese Ge utility model application KOKOKU No. 61-7735 is the external one re circumference of the coil-like spring or clock spring of the guide wire, with a relatively thin one Coating thin film applied, so that the coating thin layer has an uneven shape.

U.S. Patent No. 4,579,127 proposes a catheter and a probe support mandrel, which of a wire core and an outer wire that like a coil is wound on the wire core, best hen, and a thin coating made of synthetic resin layer with a uniform thickness is on the semicircular peripheral surface.  

The guide wire according to Japanese usage Registration KOKOKU No. 2-40992 consists of a tubular part that is free in with an inner core Contact stands, and has the disadvantage that the structure is complicated and thick. Despite their thickness, theirs is Stiffness pretty low, and still lacking the guidewire at a power transmission capacity, when it is twisted or wound.

The guide wire according to the Japanese Pa tent registration KOKAI No. 62-231675 is its narrower wire-like inner core with a relatively thick Coating layer covered so that the guidewire there tends to be thickened easily or slightly. The Stiffness of the guidewire is despite its thickness quite low. The guidewire is still missing Power transmission capacity when it twists or ver will be wounded. The guide wire according to the Japanese Utility model application KOKOKU No. 61-7735 has one coil-like spring or coil spring as a core part on so that it gives the guide wire some stiffness and one Power transmission capacity when it twists or ver is wound, is lacking. Furthermore, the succession is low towards its upper end portion.

Furthermore, the support mandrel according to the america U.S. Patent 4,579,127 discloses a structure in which an outer wire like a coil on the wire core is wound so that the guidewire, although it fle has flexibility, has low stiffness, and the guidewire lacks power transmission, when it is twisted or wound. With this structure the function of guiding a catheter or the like easily influenced. The ge Entire guide wire can be thickened to increase stiffness and improve the transmission capacity. However is such a guidewire is not an advantageous guidewire.

The present invention is in view of the problems described above providing a guide wire as a task tes with a reduced diameter, which despite its reduced diameter stiffness and excel lent leadership assets and which one excellent gliding and insertion ability in relation reached on a catheter or the like.

This task is solved by the Merk male of claim 1.

According to the present invention, a guide guidewire for use with a medical device direction provided with a hollow structure, the has: an inner core consisting of one of a Variety of wire elements formed without a strand Core part or is formed from a single wire, wherein the inner core be an outer peripheral surface sits, at least part of which is an uneven one Surface is formed; and a high polymer over train, which has an outer peripheral surface and the covered outer peripheral surface of the inner core, the outer peripheral surface of the high polymer over train has an uneven surface, which due to the un flat surface of the outer peripheral surface of the in neren core is formed or shaped.

According to the guide wire, an uneven surface che on the outer peripheral surface of the coating by an influence from the unevenness of the external order catch surface of the inner core, and as a consequence is the contact part area of the leadership wire related to a catheter or an endo Skopkanal distributed over several points. Because the contact area or the contact area is thus reduced,  the guidewire is stopped from the Kathe or the endoscope channel. The uneven Surface of the outer peripheral surface of the inner Kernes forms the outer peripheral surface of the coating into an uneven surface, so that the shape of the Un Flatness of the outer peripheral surface of the coating in a fine or precise manner and easily by appropriate selection of the shape of the unevenness of the outer Circumferential surface of the inner core can be controlled can.

Consequently, the inner core of the guidewire according to the present invention from a single Wire or strand formed without a core part. Of the inner core is covered with a coating and the on the outer periphery of the inner core flat shape appears on the outer circumference of the Coating. Accordingly, regardless of an over train with an uneven outer peripheral surface the thickness of the coating compared to the thickness of the inner core is thinned, and the guide wire is very thin and gets a high rigidity. At the same time is the assets required for an operation Excellent power transmission when the leader wire is twisted or twisted, and the successor ability of the distal end of the guide wire also excellent.

As described above, the uneven shape of the outer peripheral surface of the over due to the uneven shape of the outer order catching surface of the inner core of the guide wire is effected, according to the present invention, the con tactical portion that is in contact with a catheter, an endoscope channel or the like, to several Points distributed. In this way the contact person rich or reduce the contact area of the contact points  to prevent the guidewire from touching the Ka or the endoscope channel. Hence can the guidewire smooth there by a slight force be slid so that the guide wire smoothly or easily inserted or pulled out can.

In addition, since the uneven shape of the outer order surface of the coating along the uneven surface stalt the outer peripheral surface of the inner core is designed, the outer peripheral surface of the Coating easily by selecting the outer peripheral shape of the inner core controlled become. Accordingly, the shape of the outer Circumferential surface of the fine coating easily generated or be designed.

Furthermore, since that on the outer circumference surface of the inner core formed uneven Ge is arranged so that it is on the outer order surface of the coating appears, the thickness of the Coating compared to the thickness of the inner core be reduced, although the outer peripheral surface of the coating has an uneven shape. Dementia Accordingly, it is possible to provide a guide wire len, which is very thin and excellent rigidity owns. If the guidewire is twisted or twisted is the ability to transmit a force or the power transmission capacity, which is necessary for an Opera tion is required, excellent, and away from the body The end section of the guide wire has an excellent lent successor.

The inner core advantageously has one elongated and thin main body portion, from which at least a part made of a metal with a super elastic property exists, a distant  End portion extending from the main body portion extends and has a smaller diameter than the main body portion, and an x-ray high-contrast partial area, at the end remote from the body sub-area is provided.

In addition, the outer peripheral surface has of the inner core advantageously at least one spiral notch or spiral protrusion, which or along a longitudinal axis of the inner Kernes stretches.

At least a part of the inner core has partly a super elastic property.

Furthermore, the X-ray contains high contrast subarea as a main component any of the made of gold, silver, platinum, tungsten, bismuth oxide, palla dium and tantalum existing group of selected metal.

The X-ray high-contrast partial area points advantageously a coil-like shape or a tubular shape.

At least part of the high polymer coating be advantageously consists of one of fluorine based resin, polyethylene, polyester, polypropylene, Polyamide, polyurethane, polystyrene, their elastomers, Polyvinyl chloride and silicone rubber existing group pe selected material.

The high polymer coating advantageously has lubrication on the outer peripheral surface layer or lubricant layer, and the lubrication layer or lubricant layer advantageously has se a lubrication material or lubricant material  with which a portion of the outer circumferential upper surface of the high polymer coating is applied.

Furthermore, the guide wire can advantageously se can be used for digestive organs.

The sub-claims relate to advantageous Embodiments of the invention.

Additional tasks, details, features and Advantages of the invention result from the following the description of preferred embodiments based on of the drawings and are partly from the description exercise can become obvious or can be tion of the invention can be learned. The tasks and Advantages of the invention can be achieved by means of the following especially highlighted devices and their combination be recognized and preserved.

The accompanying drawings, which to the Offen belong to and form part of the specification, currently illustrate preferred embodiments men of the invention and serve together with the above ge general description and given below NEN detailed description of preferred embodiment shapes to explain the principles of the invention.

Show it:
Figures 1A and 1B are cross-sectional views in the longitudinal direction or transverse direction of a medical guide wire according to a first embodiment of the present invention.
Figs. 2A and 2B are cross-sectional views in the longitudinal direction or transverse direction of a medical guide wire according to a second embodiment of the present invention.

First Embodiment

FIGS. 1A and 1B show a medical guide wire according to a first embodiment of the present invention.

(Structure)

The guidewire 1 is integrally composed of an inner core 2 , which is formed from a single wire with elasticity, and a synthetic resin (made of a high polymer or high molecular weight compound) coating 3 , which essentially comprises all of the interior Core 2 covers. The guide wire 1 according to the present invention has, for example, an outer diameter of about 0.2 to 0.8 mm and a total length of about 2 to 3 meters and is designed as a guide wire for a digestive organ, which is useful when it is for example, is used together with a duodenal drainage tube or an endoscope.

The inner core 2 consists of an integral part of a main body portion 4 , which is relatively thick and stiff, and a distal Endteilbe rich 5 , which has a smaller diameter than the main body portion 4 and tapered to gradually thin. The inner core 2 is made of an elastic material, for example a pseudo-elastic metal such as stainless steel (SUS) or the like, or is made of a super-elastic metal or the like which contains nickel and titanium as its main components. Superelastic alloys containing nickel and titanium as the main components are suitable for the inner core 2 . In addition, only the partial area in the side of the upper end, which requires sufficient elasticity, can be formed from superelastic metal.

A notch 6 or a protrusion that spirally extends along the direction of the axis is formed on the outer periphery of the inner core. More specifically, as the wires shown in a second embodiment to be described later, the notch or the protrusion forms in the same uneven shape of the outer peripheral surface that is obtained by twisting three wires together. Of course, the notch 6 or the projection may have a shape other than a spiral shape. Likewise, the notch 6 or the projection may have a suitable cross sectional shape other than the shape defined by the curves shown in FIG. 1B.

An X-ray high contrast portion 7 is provided at or on the front end portion of the distal end portion 5 of the inner core 2 . The high-contrast x-ray region 7 is covered with a coating 3 . The x-ray high-contrast partial area 7 is, for example, a thin wire which is wound like a coil, or a thin layer-like or film-like partial area with a cylindrical shape. The portion 7 material may be gold, silver, platinum, tungsten, bismuth oxide, palladium, tantalum, or an alloy containing any of them as its major component, or may advantageously be platinum.

The outer peripheral surface of the inner core 2 is tightly coated with a coating 3 having a uniform thickness, and the coating 3 is applied so that it is tightly fitted to the outer peripheral surface of the inner core 2 , and a wavy de uneven surface 8 , which corresponds to the shape of the outer peripheral surface of the inner core 2 , de defines the outer peripheral surface of the coating 3rd The coating on or to the outer peripheral surface of about 3 formed uneven portion B can be over the entire coating 3 of time be provided or may be provided only at the portion where a high resistance is generated, introduced when the Füh approximately wire and is pulled out .

The material of the coating 3 can advantageously synthetic resin or in particular fluorine-based resin, such as PTFE or the like. However, other resin materials (e.g., polyethylene, polyester, polypropylene, polyamide, polyurethane, polystyrene, their elastomers, or elastomers containing polyvinyl chloride, silicone rubber, or the like) can also be used.

The coating 3 on the outer circumferential surface of the inner core 2 can be applied by means of immersion or loading or can be formed by means of thermally induced shrinking of a tube consisting of thermally shrinkable resin and adapted to or on the inner core 2 . The shape of the uneven surface 8 appearing on the outer peripheral surface of the cover 3 (e.g., the depth and / or the pitch or pitch of its notch (s)) can be easily controlled by the shape of the outer peripheral surface of the inner core 2 will.

In the present embodiment, a thin lubricant layer 9 is provided on all or part of the outer peripheral surface of the cover 3 . The lubrication layer or lubricant layer 9 may consist of a lubrication material or lubricant material such as, for example, a silicone oil or the like, with which the surface is applied, or a hydrophilic material (which is advantageously polyvinyl alcohol, polyvinylpyrrolidone or the like), depending on necessity .

(Operation and benefits)

For example, when a catheter is actually guided by the guidewire 1 , the contact area that is in contact with inner surfaces of the catheter or an endoscope channel is with the uneven surface 8 on the outer Circumferential surface of a coating 3 , with which the outer circumferential surface of the inner core 2 is coated or coated, so that the guide wire is prevented from adhering to the inner surface of the catheter or endoscope channel. Both the guide wire and the catheter are allowed to slide smoothly or slightly with a slight or small force, so that the guidance of the catheter and the insertion into the endoscope channel is facilitated or made easy. The surface of the cover of the present invention facilitates insertion and retraction of the guidewire 1 , which is much easier compared to a conventional guidewire with a flat surface made of synthetic resin.

More specifically, the outer peripheral surface of the guidewire 1 according to the present invention has an uneven shape, so that the contact portion rich in contact with the inner surface of the catheter, the endoscope channel or the like is multi-point on the uneven Shape of the outer peripheral surface of the guide wire is distributed when the guide wire 1 is inserted into a catheter, a digestive organ or an endoscope channel. Thus, the guidewire 1 slides much better than the conventional guidewire with a smooth and flat surface, and the guidewire 1 can be smoothly inserted and pulled out.

Also in the guide wire 1 according to the present invention, a single wire inner core 2 with a coating 3 is coated, and the shape of a formed on or on the outer peripheral surface of the inner core 2 is a notch 6 or a projection so arranged or designed that it appears on or on the outer circumferential surface of the coating 3 . Consequently, despite a coating 3 which forms a fine uneven surface 8 on the outer peripheral surface, the coating 3 can be thinned or thinned compared to the thickness of the inner core 2 of the guide wire 1 . As a result, it is possible to provide a guide wire 1 with excellent regenerative ability and high rigidity even if the guide wire is very thin. In addition, since the inner core 2 is made of a single wire, the guidewire has excellent transmission ability when the guidewire is twisted and the distal end portion of the guidewire also has excellent follow-up ability.

Furthermore, the guide wire 1 slides into a catheter, an endoscope channel or the like, and can be inserted or pulled out smoothly or easily. Accordingly, the guidewire 1 can be used for a catheter having an inner diameter that is much closer to the outer diameter of the guidewire 1 .

The shape of the uneven surface 8 formed on the outer peripheral surface of the guide wire 1 can be easily controlled by appropriately selecting the shape of the outer peripheral surface of the inner core 2 so that even a fine outer peripheral shape can be easily formed.

In the present invention, the guide wire 1 according to the present invention can be used in a situation in which it is not possible to insert and withdraw a conventional guide wire by providing lubricity for the outer peripheral surface of the coating of the guide wire 1 is provided.

Second Embodiment

Figs. 2A and 2B show a medical guide wire according to a second embodiment of the present invention.

(Structure)

The guide wire 11 according to the second embodiment has an inner core 12 which consists of a strand without a core part, and the strand has three wires or wire elements which are twisted together. Each of the wires 13 of the inner core 2 consists of an elastic material, for example a pseudoelastic metal such as. B. stainless steel (SUS) or the like, or of a super-elastic metal or the like, which contains nickel and titanium as its main components. A super-elastic metal containing nickel and titanium as its main components is also advantageously used for the wires 13 . Of course, at least the partial areas of the wires 13 at or on the end portions remote from the body, which require sufficient elasticity, can consist of superelastic metal. The other components of the structure are the same as those of the guide wire 1 according to the first embodiment described above.

(Operation and benefits)

In the guide wire 11 according to the second embodiment, the inner core 12 is formed from a strand without a core part, so that the inner core 12 can be made very thin and it is possible to form a guide wire 11 with excellent flexibility, excellent kink resistance, excellent regeneration capacity and high rigidity. In addition, since the inner core 12 is formed from a strand without a core part, the transmission capacity required during an operation when the guide wire 11 is twisted is much better than in the case where the coil-wound wire is used for the inner core. As a result, the follower of the distal end portion of the guide wire is improved. In addition, even if the wires 13 of the inner core 12 are made of stainless steel (SUS) or the like, it is possible to obtain substantially the same torque transmission capacity as that in the case where the inner one made of the single wire 13 is obtained Core 12 is made of super elastic metal.

In addition, it is possible to operate the same and same benefits as those described in the above  ben first embodiment were obtained to achieve chen.

The wires 13 of the inner core 12 according to the prior invention can be constructed by combining wires 13 made of different materials, with different diameters or with different cross-sectional shapes. The guidewire according to the present invention also includes a medical guidewire used for circulatory organs rather than digestive organs.

In summary, the present invention a reduced diameter guidewire ready, which despite its reduced diameter Rigidity and excellent leadership are guaranteed and which has excellent gliding ability and an excellent insertion / extraction ability in terms of reached a catheter or the like. The leader wire has one of a variety of wires elements formed strand exist without a core part the one or a single wire inner core with an uneven surface on its outer peripheral surface, a high polymer coating, which is the outer peripheral surface of the inner core densely covered, and one on the outer peripheral surface surface of the high polymer coating by means of an influence from the uneven surface on the outer circumference surface formed of the inner core te uneven surface.

Additional benefits and modifications will be Experts can easily think of it. Hence the invention in its full aspects not on those shown here and described specific details and prompt illustrative embodiments limited. Hence various modifications can be made without  of the scope and the general invent concept as defined by the appended claims che and their equivalents are defined chen.

Claims (10)

1. guidewire for use with a medical device with a hollow structure comprising:
an inner core ( 2 , 12 ) having a strand formed from a plurality of wire elements ( 13 ) without a core part or a single wire, the inner core having an outer peripheral surface, at least part of which is formed as an uneven surface ; and
a high polymer coating having an outer peripheral surface ( 3 ) and covering the outer peripheral surface of the inner core ( 2 , 12 ), the outer peripheral surface of the high polymer coating having an uneven surface through the uneven surface ( 8 ) of the outer peripheral surface of the inner Core is formed. 2. guidewire according to claim 1, characterized in that the inner core ( 2 , 12 ) has an elongated thin main body portion ( 14 ), of which we least a part consists of a metal with a super elastic property, a distal end portion ( 5 ) extending from the main body portion ( 14 ) and having a diameter smaller than that of the main body portion, and an X-ray high contrast portion ( 7 ) provided at the distal end portion. 3. Guide wire according to claim 1, characterized in that the outer circumferential surface of the inner core ( 2 , 12 ) has at least one spiral notch ( 6 ) or a spiral projection which he or he stretches along a longitudinal axis of the inner core. 4. Guide wire according to claim 1, characterized in that at least part of the inner core ( 2 , 12 ) has a super-elastic property. 5. guidewire according to claim 2, characterized in that the X-ray high-contrast portion ( 7 ) contains any metal selected from the group consisting of gold, silver, platinum, tungsten, bismuth oxide, palladium and tantalum as a main component. 6. Guide wire according to claim 2, characterized in that the high-contrast X-ray portion ( 7 ) has a coil-like shape or a tubular shape. 7. guidewire according to claim 1, characterized in that at least part of the high polymer coating ( 3 ) made of one of fluorine-based resin, polyethylene, polyester, polypropylene, polyamide, poly urethane, polystyrene, their elastomers, polyvinyl chloride and silicone rubber existing group of selected material. 8. guidewire according to claim 1, characterized in that the high polymer coating ( 3 ) on the outer ren peripheral surface has a lubricant layer ( 9 ). 9. guidewire according to claim 8, characterized in that the lubricant layer ( 9 ) has a Gleitmit telmaterial, with which a portion of the outer peripheral surface of the high polymer coating is struck. 10. Guide wire according to claim 1, characterized in that the guide wire ( 1 ) is suitable for digestive organs.